Comparison of the Bilateral Sequential and Simultaneous Cochlear Implantation in the Deaf Children (Cochleo)

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ClinicalTrials.gov Identifier: NCT01499901

Recruitment Status :
Withdrawn
(Recommendations of HAS have changed, the study is now useless)

In France the indication of bilateral cochlear implant (CI) is limited to specific cases. The impact on perception and language of bilateral CI simultaneous versus sequential has to be established before discussing the enlargement of indications.

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Ages Eligible for Study:

8 Months to 38 Months (Child)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Deep bilateral congenital deafness.

Age at the implantation: from 10 to 40 months, included.

Criteria for indication of unilateral implantation (those considered by the HAS (2007))

Deep bilateral deafness

Threshold prosthetic equal or above 60 dB

Intelligibility test in open list, below 30%, (to children under 3 years old : raw score in the questionnaire of the M.A.I.S. (72) below 15 with 2 apparatus)

No medical nor radiologic contraindication

Entitled child for welfare (excepted medical state aids)

French spoken at home

Agreement firms for the study by the two genitors

Exclusion Criteria:

Neurologic and/or psychiatric known related disorders

Malformation of the inner ear: the MRI scanners are routine examinations, in case of a cochlear implantation evaluation.